Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions - Full Text View

Purpose

The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Condition	Intervention
Bipolar Disorder	Drug: Lithium

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Official Title:	A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Fourteen day washout ] [ Designated as safety issue: No ]

Enrollment:	29
Study Start Date:	April 2003
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to lithium, or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601536

Locations


United States, Pennsylvania
	Novum Pharmaceutical Research Services
	Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

Roxane Laboratories

Investigators


Principal Investigator:	Shirley A Kennedy, MD	Novum Pharmaceutical Research Services

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	LITH-11
First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00601536
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Mood Disorders

Lithium Carbonate

Psychotic Disorders

Lithium

Additional relevant MeSH terms:

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antipsychotic Agents

Antimanic Agents

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601536